(57 days)
Not Found
No
The summary describes a robotic bronchoscopy platform with electromagnetic navigation that integrates pre-operative CT scans. While it involves image processing for navigation, there is no mention of AI or ML being used for image analysis, decision support, or robotic control. The control is described as "continuous and direct control by a physician operator."
Yes.
The device's intended use explicitly states it is for "diagnostic and therapeutic procedures" and enables "precise access of the lung anatomy" for these purposes.
Yes
The intended use explicitly states "diagnostic and therapeutic procedures" and the device provides "bronchoscopic visualization of and access to patient airways" which are often for diagnostic purposes such as biopsies or observation.
No
The device description explicitly details multiple hardware components including a cart, tower, bronchoscope, robotic arms, and field generators, indicating it is a hardware-based system with integrated software.
Based on the provided information, the Monarch Platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures." This describes a procedure performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details a robotic system with a bronchoscope, camera, and working channel for accessing and visualizing the airways. This is an invasive medical device used for direct examination and intervention within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing information about a patient's health status based on such analysis. IVD devices are specifically designed for testing samples outside of the body.
The Monarch Platform is a medical device used for performing procedures within the patient's body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Monarch Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
EOQ, JAK
Device Description
The Monarch Platform is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Monarch Platform enables robotic electro-mechanical articulation and precise control of a flexible bronchoscope under continuous and direct control by a physician operator. The Monarch Platform allows for precise access of the lung anatomy and continuous visualization using the bronchoscope distal tip camera.
The Monarch Platform consists of three major components, (1) Monarch Cart, (2) Monarch Tower, and (3) Monarch Bronchoscope, and working channel instruments and accessories. The Monarch Cart provides support for the robotic arms. It includes up to three robotic arms and the electronic systems required to power and operate the robotic system. The flexible Monarch Bronchoscope has a working channel and a camera at the tip. The working channel of the Bronchoscope is used for irrigation, aspiration and to deliver the working channel instruments.
Additionally, the Monarch Platform includes electromagnetic (EM) navigation that integrates a pre-operative computed tomography (CT) scan into an intra-operative interface. displaying the modeled bronchoscope tip location relative to the preoperative scan anatomy. Two options of field generators are available to enable electromagnetic navigation. The current Monarch Navigation Field Generator and a new Window Field Generator (WFG). The new WFG is being added to increase compatibility of the Monarch system with advanced imaging systems (Cone Beam and Mobile CT).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT) scan
Anatomical Site
patient airways, lung anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician operator
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing for the new Window Field Generator and the Monarch system were conducted to ensure that the system performs as intended and to ensure the changes outlined in this submission do not raise different questions of safety or effectiveness. Verification testing included electrical safety and electromagnetic compatibility, software, and performance specifications verification testing. In addition to design verification, confirmatory validation testing was performed to ensure the device meets its Clinical Input Requirements (CIR) for its intended use. Validation Testing included evaluations of the pertinent parts of workflow impacted by this change with accredited bronchoscopists. Overall, device performance testing showed that the differences in technological characteristics do not raise different questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 9, 2021
Auris Health, Inc. Shikha Gola Director of Regulatory Affairs 150 Shoreline Drive Redwood, California 94065
Re: K211493
Trade/Device Name: Monarch Platform Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: June 15, 2021 Received: June 21, 2021
Dear Shikha Gola:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part
1
801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Shu-Chen Peng Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211493
Device Name Monarch Platform
Indications for Use (Describe)
The Monarch Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number K211493
I. SUBMITTER
Address: Auris Health, Inc. 150 Shoreline Drive, Redwood City, CA 94065
Contact Person:
Shikha Gola Director, Regulatory Affairs sgola@its.jnj.com 201-240-3891
Date Prepared: May 11, 2021
II. DEVICE
| Manufacturer: | Auris Health, Inc. |
|---|---|
| Trade/Proprietary Name: | Monarch Platform |
| Common Name: | Bronchoscope (flexible or rigid) and accessories |
| Product Code: | EOQ |
| Regulatory Class: | Class II |
| Classification: | 21 CFR 874.4680 Bronchoscope (flexible or rigid) and accessories |
| Product Codes: | EOQ, JAK |
III. PREDICATE DEVICE(S)
| Manufacturer: | Auris Health, Inc. |
|---|---|
| Trade/Proprietary Name: | Monarch Platform |
| 510(K) | K193534 |
| Classification: | 21 CFR 874.4680 Bronchoscope (flexible or rigid) and |
| accessories | |
| Product Codes: | EOQ, JAK |
4
IV. DEVICE DESCRIPTION
The Monarch Platform is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Monarch Platform enables robotic electro-mechanical articulation and precise control of a flexible bronchoscope under continuous and direct control by a physician operator. The Monarch Platform allows for precise access of the lung anatomy and continuous visualization using the bronchoscope distal tip camera.
The Monarch Platform consists of three major components, (1) Monarch Cart, (2) Monarch Tower, and (3) Monarch Bronchoscope, and working channel instruments and accessories. The Monarch Cart provides support for the robotic arms. It includes up to three robotic arms and the electronic systems required to power and operate the robotic system. The flexible Monarch Bronchoscope has a working channel and a camera at the tip. The working channel of the Bronchoscope is used for irrigation, aspiration and to deliver the working channel instruments.
Additionally, the Monarch Platform includes electromagnetic (EM) navigation that integrates a pre-operative computed tomography (CT) scan into an intra-operative interface. displaying the modeled bronchoscope tip location relative to the preoperative scan anatomy. Two options of field generators are available to enable electromagnetic navigation. The current Monarch Navigation Field Generator and a new Window Field Generator (WFG). The new WFG is being added to increase compatibility of the Monarch system with advanced imaging systems (Cone Beam and Mobile CT).
V. INDICATIONS FOR USE
The Monarch Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Monarch Platform is substantially equivalent to the predicate device with respect to the device function, design and indications of use. There are no changes to the key components of the Monarch Platform which includes the Monarch Cart, Monarch Tower and Monarch Bronchoscope. The proposed device modifications introduced the Window Field Generator (WFG) as an optional accessory for customers for increased mechanical compatibility with advanced imaging systems. This new WFG has the same core technological characteristics as the current Monarch Field Generator but is secured under the patient bed to optimize mechanical compatibility. Both EM field generators perform the same function for the Monarch Platform. Minor software changes were also made to the arm kinematics to better accommodate high patient bed heights. Additionally, navigation was updated for smoother virtual views when transitioning between predicted airways. These updates helped improve the navigation image displayed on the user interface. An additional condition for which a "Segmentation
5
Failure" notification would be triggered during the procedure planning step was also added. Lastly the red saturation in the live endoscopy view was reduced to better reflect real tissue coloration. These changes did not impact the core technological characteristics of the Monarch Platform.
| Device
Characteristics | Predicate Device
Auris Health, Inc.
Monarch Platform (K193534) | Subject Device (K211493) |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Regulation Number | 21 CFR §874.4680, Bronchoscope
(flexible or rigid) and accessories | Same |
| Class | II | Same |
| Product Code | EOQ, Bronchoscope (Flexible Or
Rigid) | Same |
| Intended Use | JAK, System, X-Ray,
Tomography, Computed
The Monarch Platform and its
accessories are intended to
provide bronchoscopic
visualization of and access to
patient airways for diagnostic and
therapeutic procedures. | Same |
| Contraindications for
Use | Contraindications include but are
not limited to:
• Patient whose general health or
respiratory function or both are
compromised to the point that the
patient would not tolerate flexible
bronchoscopy.
• Absence of a trained
bronchoscopist to perform or
closely and directly supervise the
procedure, as well as manage
complications common to flexible
bronchoscopy.
• Use of the system in patients
with electrically or magnetically
activated implanted medical
devices | Same |
VII. PERFORMANCE DATA
Verification and validation testing for the new Window Field Generator and the Monarch system were conducted to ensure that the system performs as intended and to ensure the changes outlined in this submission do not raise different questions of safety or effectiveness. Verification testing included electrical safety and electromagnetic
6
compatibility, software, and performance specifications verification testing. In addition to design verification, confirmatory validation testing was performed to ensure the device meets its Clinical Input Requirements (CIR) for its intended use. Validation Testing included evaluations of the pertinent parts of workflow impacted by this change with accredited bronchoscopists. Overall, device performance testing showed that the differences in technological characteristics do not raise different questions of safety or effectiveness.
VIII. CONCLUSION
The modified device in this submission does not affect the intended use of the device or alter the fundamental scientific technology of the device. Summary information for the design control process serves as the basis for this submission. The Monarch Platform is substantially equivalent to the legally marketed predicate device based upon intended use, technological characteristics and performance testing.